Antibiotics vs Corticosteroids in Treatment of Granulomatous Lobular Mastitis (GRANMAS)

Antibiotics vs Corticosteroids in Treatment of Granulomatous Lobular Mastitis - A Randomized Controlled Trail

The goal of this clinical trial is to find the most effective and safe medical treatment for Granulomatous Lobular Mastitis (GLM) - a rare, chronic inflammatory breast disease that affects young and middle-aged women, often following childbirth.

The main questions it aims to answer are:

Does an antibiotic regimen (clarithromycin, ofloxacin, rifaximin) lead to faster and complete healing (Complete Clinical Response) compared to steroids?

Do steroids (prednisolone in tapering doses) provide better symptom control or cause more side effects?

Researchers will compare the antibiotic group (Group A) and the steroid group (Group B) to see which treatment results in quicker recovery, fewer side effects, and lower recurrence rates.

Participants will:

Receive a 14-day antibiotic trial initially (screening phase).

If no improvement, be randomly assigned to:

Group A (Antibiotic therapy) - Clarithromycin, Ofloxacin, Rifaximin for 8 weeks, or

Group B (Steroid therapy) - Prednisolone in tapering doses for 8 weeks.

Undergo evaluation after 2 months:

If not fully recovered, receive Methotrexate + Folic acid for another 8 weeks.

If still no improvement, switch to the alternate treatment or undergo surgery if required.

Attend regular follow-ups for 6 months for clinical assessment and monitoring of side effects.

This 2-year study aims to develop a standardized, step-by-step treatment protocol for GLM, helping improve outcomes and reduce unnecessary surgeries for affected women.

Study Overview

• Status: Not yet recruiting
• Conditions: Granulomatous Mastitis
• Intervention / Treatment: Drug: Steroid; Drug: Antibiotic

Detailed Description

What is this study about?

This research is being done at AIIMS Bhubaneswar to find the best medical treatment for a breast condition called Granulomatous Lobular Mastitis (GLM).

GLM is a rare, long-lasting inflammation of the breast that mainly affects young and middle-aged women, often those who have recently had children. It can look very similar to breast cancer or a breast abscess, causing anxiety and sometimes unnecessary surgery.

Common symptoms include:

Painful or painless breast lump

Swelling, redness, or abscess (collection of pus)

Discharge from the nipple or retraction (nipple pulled inward)

Skin changes over the breast It can occur in one or both breasts and may come back after treatment.

Why is this study important?

At present, there is no single, standard treatment for GLM. Doctors use antibiotics, steroids, immunosuppressants (like methotrexate), or surgery - but the results vary widely. Some medicines help one patient but not another, and some cause unwanted side effects or recurrences.

This study aims to compare antibiotics and steroids directly, to identify which gives better and faster healing with fewer side effects. The goal is to develop a clear, step-by-step treatment plan for all patients with GLM.

What will happen in this study? Who can take part?

Women diagnosed with GLM by biopsy (tissue test).

Participants must be willing to attend regular follow-ups.

Women who are pregnant, breastfeeding, diabetic (uncontrolled), on other immunosuppressive treatment, or allergic to study drugs cannot participate.

How the study works:

First step (screening):

All participants will receive a short course of antibiotics for 14 days.

If the infection improves, treatment continues outside the study.

If it doesn't improve, the person will be included in the main trial.

Random assignment:

Patients will be randomly divided into two groups:

Group A - Antibiotic group: Receives clarithromycin, ofloxacin, and rifaximin tablets for 8 weeks.

Group B - Steroid group: Receives prednisolone (steroid tablets) in reducing doses for 8 weeks.

Review after 2 months:

Doctors will check whether the breast swelling and pain are gone.

If completely cured (called Complete Clinical Response or CCR), medicines are stopped.

If not cured, the patient is given an additional medicine (methotrexate + folic acid) for 8 weeks.

If still not improved:

The treatment groups are switched (antibiotic patients receive steroids, and vice versa).

If there's still no recovery, surgery (like abscess drainage or lump removal) will be considered.

Throughout the study, symptoms, side effects, and any need for surgery will be recorded carefully.

How long does participation last?

Each participant will be followed for around 6 months - this includes treatment, monitoring, and follow-up visits.

Possible benefits for participants

Regular medical check-ups, follow-ups, and investigations by specialist doctors.

Chance of receiving an effective, well-monitored treatment plan.

Early detection of complications and quick medical management.

Contribution to medical knowledge that may help future patients avoid prolonged or incorrect treatment.

Possible side effects or risks

All medicines used in this study are commonly prescribed and generally safe under supervision.

However, possible side effects may include:

For antibiotics: stomach upset, nausea, mild diarrhea, or allergy (rare).

For steroids: weight gain, bloating, mood changes, increased appetite, or joint pain.

For methotrexate: mild fatigue, nausea, or rare liver enzyme changes (monitored closely).

Doctors will monitor all participants closely and adjust or stop treatment if any problems arise.

Any abscess or fluid collection will be drained if needed, and pain will be managed with appropriate medicines.

Confidentiality and voluntary participation

All personal information will be kept strictly confidential. Participants' names will not appear in any reports or publications. Joining this study is completely voluntary. You may leave the study at any time without affecting your future medical care.

Costs and compensation

All investigations and medicines that are part of routine care are free or low-cost.

The average expected expense is about ₹2500, which includes only the patient's regular medical costs.

If any research-related injury occurs, the hospital will provide free treatment.

Expected outcomes

By comparing results between antibiotics and steroids, this study aims to:

Identify which treatment helps more women achieve complete healing faster.

Understand which drugs have fewer side effects.

Reduce the need for surgery and recurrence.

Develop a standardized treatment protocol for GLM.

If antibiotics are found to be equally effective or better, they could become the first-line, low-cost, safer option - especially in areas with limited resources.

If steroids prove superior, their dosage and duration can be refined to minimize side effects.

Study time - 2 years

• Study Type: Interventional
• Enrollment (Estimated): 72
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Maniteja Ravipati, MBBS; Phone Number: +91 7619508903; Email: maniteja.ravipati@gmail.com
• Study Contact Backup: Name: Tushar Subhadarshan Mishra, MBBS,MS; Phone Number: +91 9438884251; Email: surg_tushar@aiimsbhubaneswar.edu.in

Study Locations

• India
  • Odisha
    • Bhubaneswar, Odisha, India, 751019
      • AIIMS Bhubaneswar
      • Contact: Maniteja R, MS; Phone Number: 7619508903; Email: maniteja.ravipati@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Women histologically diagnosed with GLM willing to participate in the study and to come for follow up.

Exclusion Criteria:

• Declining to participate in the study
• Pregnant or lactating women
• Patient already on antibiotic/steroid therapy and are responding to treatment
• Known immunosuppression or diabetes mellitus uncontrolled
• Patient already on immunosuppression therapy for any other disorder
• Lost to follow-up before 3 months post-treatment
• Allergic to one of the antibiotics/steroids which will be used
• Contraindications to oral steroids therapy
• Contraindications to methotrexate therapy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: ARM Corticosteroid; Steroids are used to treat GLM	Drug: Steroid; Once randomized into the steroid arm, oral therapy with Tab. Prednisolone 20mg BD will be given for 14days, Tab. Prednisolone 10mg BD will be given for 21 days, Tab. Prednisolone 5mg BD will be given for 14days and Tab. Prednisolone 2.5mg BD will be given for 7 days(tapering dose) will be used in this intervention compared to antibiotics which are used in other. If the rate of response to oral steroids is slow and therapy prolonged, intralesional steroids (Inj. Triamcinalone 40mg) will be given as deemed required.; Other Names: Tab Prednisolone; Inj Triamcinalone
Active Comparator: ARM Antibiotic; Antibiotics are used to treat GLM	Drug: Antibiotic; Once randomized into the antibiotic arm, dual oral antibiotic therapy with Ofloxacin 400mg and Clarithromycin 500mg will be used in this intervention compared to steroids which are used in other; Other Names: Tab Clarithromycin 500; Tab Ofloxacin 400

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary outcome	To compare the efficacy of antibiotics vs corticosteroids in achieving Complete Clinical Response (CCR) via clinical and radiological assessment in GLM patients at two months of the treatment started in the adaptive randomized arm. CCR will be defined as no clinical signs and symptoms of the disease and no recurrence for 6 weeks.	2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To assess the safety and tolerability of each treatment regimen	To assess the safety and tolerability of each treatment regimen via clinical assessment leading to the detection of any side effects, namely weight gain, skin changes, diabetes mellitus, bone pain, menstrual irregularities, hirsuitism, cataract, glaucoma, joint pains, tendonitis, skin ulcers, and heart rhythm changes. Any of the above side effects, debilitating enough to warrant stoppage of therapy will define tolerability. Development of irreversible side effects will define safety of the treatment regimen.	2 months
To assess the the proportion of patients requiring surgery in the treatment of GLM	Determining the proportion of patients requiring surgery, based on surgical procedures performed on basis of clinical examination findings suggestive of abscess. Aspiration and minisuction drain(6 french aspiration catheter/pigtail) will be not be considered as a surgical procedure	2 months
To assess the role of different quantum of surgery needed (Incision and Drainage/Resection/mastectomy) in the treatment of GLM	Determining the Quantum of surgery needed (Incision and Drainage/Resection/mastectomy), based on surgical procedures performed on basis of clinical examination findings suggestive of abscess. Aspiration and minisuction drain(6 french aspiration catheter/pigtail) will be not be considered as a surgical procedure	2 months
To assess the number of patients have recurrence after surgery in the treatment of GLM	Determining the number of patients have recurrence after surgery performed in the institution or outside, based on surgical procedures performed on basis of clinical examination findings suggestive of abscess. Aspiration and minisuction drain(6 french aspiration catheter/pigtail) will be not be considered as a surgical procedure	2 months
To assess the number of patients requiring Aspiration/ minisuction drain(6 french aspiration catheter/pigtail) in the treatment of GLM	Determining the number of patients requiring Aspiration/ minisuction drain(6 french aspiration catheter/pigtail) on basis of clinical examination findings suggestive of abscess.	2 months
To assess the failure rate of aspiration/ minisuction drain(6 french aspiration catheter/pigtail) in the treatment of GLM	Determining the proportion of aspiration/minisuction drain failures from procedures performed on basis of clinical examination findings suggestive of abscess.	2 months
To determine the Indications of immunosuppressive therapy in the treatment of GLM	To determine the indications of immunosuppressive therapy (failure to achieve CCR within 2 months/Relapse/cure, side effects of primary medications), started after non response to intervention arm drugs	2 months
To To determine the proportion of patient requiring combination immunosuppressive therapy in the treatment of GLM	To determine the proportion of patient requiring combination immunosuppressive therapy started after non response to intervention arm drugs	2 months
To determine the average duration of immunosuppressive therapy required in the treatment of GLM	Average duration of immunosuppressive therapy required, started after non response to intervention arm drugs	2 months
Histological pattern (neutrophilic/lymphocytic/mixed)	To compare the proportion of patients with each of the histological variety (neutrophilic/lymphocytic/mixed) of GLM attaining complete response to therapy in each arm.	2 months
Proportion of CCR obtained in each histological pattern (neutrophilic/lymphocytic)	To assess the proportion of CCR obtained in each histological pattern (neutrophilic/lymphocytic).	2 months

Collaborators and Investigators

• Sponsor: All India Institute of Medical Sciences, Bhubaneswar
• Investigators: Principal Investigator: Tushar Subhadarshan Mishra, MBBS,MS, AIIMS Bhubaneswar

Study record dates

Study Major Dates

• Study Start (Estimated): March 15, 2026
• Primary Completion (Estimated): April 4, 2027
• Study Completion (Estimated): July 4, 2027

Study Registration Dates

• First Submitted: November 17, 2025
• First Submitted That Met QC Criteria: March 4, 2026
• First Posted (Actual): March 6, 2026

Study Record Updates

• Last Update Posted (Actual): March 6, 2026
• Last Update Submitted That Met QC Criteria: March 4, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Pregnancy Complications; Skin Diseases; Breast Diseases; Puerperal Disorders; Skin and Connective Tissue Diseases; Mastitis; Granulomatous Mastitis; Anti-Infective Agents; Pharmacologic Actions; Chemical Actions and Uses; Therapeutic Uses; Polycyclic Compounds; Pregnadienes; Pregnanes; Fused-Ring Compounds; Pregnadienetriols; Prednisolone; Anti-Bacterial Agents; Steroids
• Other Study ID Numbers: ECR/534/inst/OD/2014/RR-25

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No